The Halifax SR Suite consists of two X-Ray imaging systems; the two systems are integrated through a synchronization switch. The switch allows the two X-Ray imaging systems to fire simultaneously, providing a pair of X-Ray images from different perspectives to be taken at the exact same time. This process allows for Roentgen Stereophotogrammetric Analysis (RSA). RSA is a stereo x-ray technique that enables measurements more precise than single plane radiography based on phantom precision studies. The resulting level of precision provides measurements of joint replacement stability.

The Halifax Imaging Kit is part of the SR Suite product line and provides an alternative path to creating an SR Suite. The Halifax Imaging Kit consists of FDA cleared and/or certified X-Ray components integrated into an existing digital radiography room already containing an FDA cleared x-ray imaging system to form an SR Suite. The exposures of the Halifax Imaging Kit and the existing Digital Radiography (DR) system are synchronized by replacing the trigger switches of the two systems with either the Universal Synchronization Switch or the Imaging Kit Control Module (IKCM).

The Universal Synchronization Switch or IKCM ensures the two X-Ray imaging systems fire simultaneously, therefore providing a pair of X-Ray images from two different perspectives taken at the exact same time. There are two versions of the Halifax Imaging Kits:

a) UNIVERSAL SYNCHRONIZATION (NON-GE BASED CONFIGURATION) The Universal Synchronization Switch synchronizes two independent X-ray systems as accurately as possible by using the manual pushbutton interface of each X-ray system. This replaces the synchronization switch that was described in our predicate K121345.

b) IMAGING KIT CONTROL MODULE (GE BASED CONFIGURATION) The general purpose of the IKCM is to coordinate and control the activities of the detector and workstation with the activities of the generator, as well as coordinate the exposures between the client's clinical system and the Halifax Imaging Kit for RSA exposures. The current version of the IKCM is designed specifically for interfacing with the following components:

•GEHC WDR1 Upgrade Kit which consists of a 'Flashpad' detector, a workstation named 'MagicPC', and a 'Cabinet' for power distribution and communication control. Integrating with a pre-existing system (GEHC Discovery XR656 Plus).

· EMD Technologies Epsilon Series generator. (Or generators already on site)

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Halifax Imaging Kit," a stationary digital x-ray system. The submission focuses on demonstrating substantial equivalence to a predicate device (Halifax SR Suite 1.0, K121345).

Based on the information provided in the document, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

No specific acceptance criteria table or quantitative performance metrics are explicitly stated in this 510(k) summary. The submission focuses on demonstrating "substantial equivalence" rather than proving specific performance metrics of the device itself. The primary "study" to meet acceptance criteria relies on demonstrating that the new device configuration (Halifax Imaging Kit) is as safe and effective as its predicate device and that its components (like digital panels) already have their own 510(k) clearances.

Therefore, the "acceptance criteria" here is primarily about fulfilling the FDA's requirements for substantial equivalence, rather than meeting specific quantifiable performance targets for a diagnostic or AI-driven system.

However, I can extract information related to the closest aspects of your request:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, there is no explicit table of acceptance criteria with quantitative performance metrics for this device as it's not a diagnostic AI system. The acceptance criteria for a 510(k) submission of this nature are generally qualitative and relate to safety, effectiveness, and substantial equivalence to a predicate device.

Acceptance Criteria (Inferred from 510(k) process)	Reported Device Performance (Summary of how criteria are met)
Equivalence in Intended Use	"This is a stationary digital x-ray system for general radiography and RSA (Roentgen Stereophotogrammetric Analysis procedures). Not for mammography." - Unchanged from predicate.
Equivalence in Technological Characteristics (Components)	New kit integrates FDA cleared/certified X-Ray components. Compared in a "Substantial Equivalence Chart" (Page 5-6) showing similar or equivalent components (Generator, Maximum output, Stand, Image Acquisition, Digital Panel, Digital Resolution, Software, Acquisition Software, Collimator, Safety).
Equivalence in Safety	"The results of bench and standards testing indicates that the new device is as safe and effective as the predicate device. Risk analysis has been performed." "UL listed and EMC tested power supply used in the Imaging Kit."
Equivalence in Effectiveness	"The results of bench and standards testing indicates that the new device is as safe and effective as the predicate device." "Every installation undergoes a precision validation test... a phantom study was undertaken using a small carbon fibre box. Phantom studies, commonly used for RSA validation, are a technique used to calculate in vitro precision and accuracy of an RSA System."
No New Indications for Use	"has no new indications for use"

2. Sample Size Used for the Test Set and Data Provenance

Test Set Description: The "test set" primarily refers to components, bench tests, and a phantom study.
Sample Size: Not applicable in the traditional sense of a clinical or image-based test set for an AI/diagnostic algorithm.
- For the bench testing, no "sample size" of patients or images is mentioned. It refers to testing of the Universal Synchronization Switch (board level functionality, firmware, enclosure wiring) and the Imaging Kit Control Module.
- For the phantom study (for precision validation per installation), the sample size would be the "small carbon fibre box" used for in vitro precision and accuracy calculation. No specific number of phantom images or measurements is given, but it implies a single phantom setup used for validation.
Data Provenance: Not explicitly stated for specific data points other than the general context of the company being Halifax Biomedical Inc. (Canada) and the submission to FDA (USA). The phantom study refers to validation at a "[Hospital]" in "[City]" ([Room details]), "[State/Province]", "[Country]" – implying it could be anywhere, but the company is Canadian. The data is prospective in the sense that the bench testing and phantom validation are performed as part of the device development and installation process.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This submission does not involve human expert adjudication of medical images to establish ground truth for a diagnostic algorithm. The "ground truth" for the device's functionality relates to its mechanical/electrical performance, precise synchronization, and ability to perform RSA measurements.
The "experts" would be the engineers and QA personnel performing the bench tests and the precision validation (phantom study). Their qualifications are typically implied by their roles in medical device development and testing.

4. Adjudication Method for the Test Set

Not applicable. No human image-reading adjudication method is mentioned as this is not a diagnostic imaging AI system. The "adjudication" of performance is done through objective bench test results and phantom study measurements against expected performance, rather than through consensus of human readers interpreting clinical images.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. An MRMC study was not done. This device is an X-ray system, not an AI or CAD system intended to assist human readers. The document explicitly states "Clinical testing was not required to establish equivalence because all of the new digital receptor panels already have their own 510(k) clearances."

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is an X-ray imaging system, not a standalone algorithm. While it produces images for Roentgen Stereophotogrammetric Analysis (RSA), the "algorithm" for RSA (RSA-CMS software) is stated to be "Unchanged" from the predicate device and was cleared under K042383. The submission is about the kit that acquires the images, not a new RSA analysis algorithm.

7. The Type of Ground Truth Used

Engineering specifications and physical measurements (for bench testing and phantom studies).
- For the Universal Synchronization Switch and Imaging Kit Control Module: Proper Board level functionality, firmware performance, proper enclosure internal wiring assemblies and connections.
- For the RSA System precision: In vitro precision and accuracy calculated using a phantom study (small carbon fibre box) consistent with common RSA validation techniques. This relies on the known physical properties and movements of the phantom as the "ground truth."
- For the digital receptor panels: Their own prior 510(k) clearances serve as evidence of their established performance and safety, essentially acting as their "ground truth" for those components.

8. The Sample Size for the Training Set

Not applicable. This device is an X-ray imaging system, not an AI or machine learning algorithm that requires a training set. The software for RSA analysis (RSA-CMS) is unchanged from the predicate and would have had its own development and validation process earlier, but details are not in this document.

9. How the Ground Truth for the Training Set Was Established

Not applicable. See point 8.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. The first logo is the Department of Health & Human Services - USA logo, which features a stylized human figure. The second logo is the FDA U.S. Food & Drug Administration logo, with the FDA acronym in a blue square and the full name of the administration in blue text to the right of the square.

October 31, 2018

Halifax Biomedical, Inc. % Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES, FL 34114

Re: K182880

Trade/Device Name: Halifax Imaging Kit Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR, MQB, LLZ Dated: October 11, 2018 Received: October 15, 2018

Dear Daniel Kamm:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Hole 2. Nils

for Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K182880

Device Name Halifax Imaging Kit

Indications for Use (Describe)

This is a stationary digital x-ray system for general radiography and RSA (Roentgen Stereophotogrammetric Analysis procedures). Not for mammography.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the text "510(k) Summary K182880" at the top. Below that is the logo for Halifax Biomedical Inc. The logo includes a square with arrows pointing inward and the company name in two lines, with "Halifax" in a larger, orange font and "Biomedical Inc." in a smaller, blue font.

11493 Route 19, Mabou Nova Scotia, Canada, BOE 1X0 Phone +1 902 945 2762 Fax +1 902 945 2324 Chad Munro, CEO, President Date Prepared: October 30, 2018

1. Identification of the Device:

Proprietary-Trade Name: Halifax Imaging Kit Regulation Number: 892.1680 Regulation Name: Stationary x-ray system. Regulatory Class: II Product Codes: KPR, MQB, LLZ Common/Usual Name: Stationary X-Ray System

Equivalent legally marketed device: Halifax SR Suite 1.0, K121345 Regulation Number: 892.1680 Regulation Name: Stationary x-ray system. Regulatory Class: II Product Codes: KPR, MQB, LLZ Common/Usual Name: Stationary X-Ray System

3. Contact:

Daniel Kamm, P.E., Tel 239-234-1735, Email fda.help.now@gmail.com

1. Indications for Use: This is a stationary digital x-ray system for general radiography and RSA (Roentgen Stereophotogrammetric Analysis procedures). Not for mammography.
1. Description of the Device: The Halifax SR Suite consists of two X-Ray imaging systems; the two systems are integrated through a synchronization switch. The switch allows the two X-Ray imaging systems to fire simultaneously, providing a pair of X-Ray images from different perspectives to be taken at the exact same time. This process allows for Roentgen Stereophotogrammetric Analysis (RSA). RSA is a stereo x-ray technique that enables measurements more precise than single plane radiography based on phantom precision studies. The resulting level of precision provides measurements of joint replacement stability.

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· EMD Technologies Epsilon Series generator. (Or generators already on site)

Image /page/4/Picture/5 description: The image shows a diagram of a setup with two cameras positioned at an angle of 30 degrees relative to a central point. The cameras are mounted above a black platform, and the distance from the cameras to the platform is labeled as 150 cm. The cameras are pointed downwards, and their fields of view converge on the platform, which has two objects with red lines and crosshairs on them.

1. Safety and Effectiveness, comparison to predicate device. The results of bench and standards testing indicates that the new device is as safe and effective as the predicate device. Risk analysis has been performed.
1. Substantial Equivalence Chart, Halifax Imaging Kit

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Characteristic	Halifax SR Suite 1.0 K121345	Halifax Imaging Kit Option*Utilizes existing radiography systemOR new components.
Intended Use:	This is a stationary digital x-ray system forgeneral radiography and RSA (RoentgenStereophotogrammetric Analysisprocedures.) Not for mammography.	This is a stationary digital x-ray system forgeneral radiography and RSA (RoentgenStereophotogrammetric Analysisprocedures.) Not for mammography.
Generator	Sedecal SHF635RF (Two used)	• Sedecal SHF515C or• Sedecal SHF635RF• Or equivalent Sedecal Generator• EMD Epsilon Generator(Two generators used)
Maximum output	64 kW (Two used)	45-80 kW depending on model selected(Two used) or units already in place.
Stand	Sedecal and Acceleray	Utilizes existing radiography system ORSYFM Stand
Image Acquisition	Digital, dual panels.	Digital, dual panels.
Digital Panel Size	17 x 17	17 x 17 or 14 x 17 or 16 x 16 (Flashpad)
Digital PanelSupplier	Canon CXDI-50RF (Two used, cleared inK092429)	Two of any of the following (all previouslycleared):• Agfa DX-D30C or• Canon CXDI-501G or• Canon CXDI-70C or• Canon CXDI-701C or• GE Flashpad (WDR1 Kit)• Any imaging panel with 510(k) clearancewhich meets Halifax validation criteria.
Digital Resolution	Pixel size 160 × 160 µmImage matrix size 2208 × 2688 pixelsNumber of pixels Approx. 5.9 million pixels	Agfa DX-D30C 139 µm 7.9 million pixelsCanon CXDI-501G 125 µm 9.5 million pixelsCanon CXDI-70C 125 um 9.5 million pixelsCanon CXDI-701C 125 µm 9.5 million pixels200 µm , 4.1 million pixelsGE Flashpad
Software	The SR Suite employs the software clearedin K042383, the RSA-CMS. The softwarewas designed specifically to performRoentgen Stereophotogrammetric Analysis.	Unchanged
AcquisitionSoftware	SR Suite 1.0 employs the acquisitionsoftware cleared in K092429 for the digitalpanel.	Unchanged
Collimator	Ralco R225	Ralco R225 Unchanged
Safety	UL listings and EMC Tested.	UL listed and EMC tested power supplyused in the Imaging Kit

Reference to Digital Panel Clearances:

Agfa DX-D30C K141602
Canon CXDI-501G K111682)

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Canon CXDI-70C K102012
Canon CXDI-701C K131106
GE Flashpad (WDR1 Kit) K102116

8. Summary of Bench Testing and development activities conducted:

The following Risk Management and Risk Analysis documents were created:

Risk Management Plan - Halifax Imaging Kit Risk Management Plan - Imaging Kit Control Module Risk Analysis - Imaging Kit Control Module Risk Analysis - Halifax Imaging Kit - L-Arm Support Fault-Tree Analysis - Imaging Kit Control Module

Design Verification Testing of the Universal Synchronization Switch was performed in order to verify (a) Proper Board level functionality, firmware and (b) Proper Enclosure internal wiring assemblies and connections. Finite element analysis was performed on the support structures followed by design verification reviews.

Verification and Validation reports were executed for the new Imaging Kit, Control Module, and Universal Synchronization Switch.

Labeling: Installation and User Manuals were developed for the modified portions of the system, and the original labeling was updated according to the FDA Guidance on Cybersecurity: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, Guidance for Industry and Food and Drug Administration Staff Document Issued on: October 2, 2014.

The following reports were prepared documenting bench testing activities:

Design Verification Test, Universal Synchronization Switch

Imaging Kit Control Module Verification Report

Imaging Kit Control Module Validation Test Report

In addition a Requirements Traceability analysis was performed for the Imaging Kit Control Module. The power supply chosen for the Imaging Kit Control Module is UL listed and EMC compliant for medical applications per IEC Standards: IEC 60601-1 and IEC 60601-1-2.

Every installation undergoes a precision validation test prior to turn over to the customer. "The precision of a Radiostereometric Analysis (RSA) System is affected by the components of the RSA System set-up as well as by the features of the individual joint and implant under examination. To validate a new Halifax Imaging Kit at "[Hospital]" in [City] ([Room details]), [State/Province], [Country], a phantom study was undertaken using a small carbon fibre box. Phantom studies, commonly used for RSA validation [1-12], are a technique used to calculate in vitro precision and accuracy of an RSA System."

1. Summary of Clinical Testing: Clinical testing was not required to establish equivalence because all of the new digital receptor panels already have their own 510(k) clearances.
1. Conclusion: After analyzing bench testing, standards testing data, and risk analysis it is the conclusion of Halifax Biomedical that the Halifax Imaging Kit Option is as safe and effective as the predicate device, has no significant technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device.

Regulation Number and Section

§ 892.1680 Stationary x-ray system.

(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.